Cinacalcet hydrochloride maintains long-term normocalcemia in patients with primary hyperparathyroidism

Munro Peacock, John P. Bilezikian, Preston S. Klassen, Matthew D. Guo, Stewart A. Turner, Dolores Shoback

Research output: Contribution to journalArticle

339 Citations (Scopus)

Abstract

Calcimimetics increase the sensitivity of parathyroid calcium-sensing receptors to extracellular calcium, thereby reducing PTH secretion. This multicenter, randomized, double-blind, placebo-controlled study assessed the ability of the oral calcimimetic cinacalcet HCl to achieve long-term reductions in serum calcium and PTH concentrations in patients with primary hyperparathyroidism (HPT). Patients (n = 78) were randomized to cinacalcet or placebo. Cinacalcet was titrated from 30-50 mg twice daily during a 12-wk dose-titration phase. Efficacy was assessed during 12-wk maintenance and 28-wk follow-up phases. The primary endpoint was the achievement of normocalcemia [serum calcium ≤ 10.3 mg/dl (2.57 mmol/liter)] with at least 0.5 mg/dl (0.12-mmol/liter) reduction from baseline. Plasma PTH, serum and urine biochemistry, biochemical measures of bone turnover, bone mineral density, and safety were also assessed. Seventy-three percent of cinacalcet-treated patients vs. only 5% of placebo-treated patients achieved the primary endpoint (P < 0.001). Fasting predose plasma PTH decreased 7.6% in cinacalcet patients but increased 7.7% in placebo patients (P < 0.01). Bone mineral density was unchanged by cinacalcet, but bone resorption and formation markers increased (P < 0.05). Adverse events were mild and similar between treatment groups. Cinacalcet rapidly normalizes serum calcium and reduces PTH in patients with primary HPT, and these effects are maintained with long-term treatment. Cinacalcet may be an effective, nonsurgical approach for management of primary HPT.

Original languageEnglish
Pages (from-to)135-141
Number of pages7
JournalJournal of Clinical Endocrinology and Metabolism
Volume90
Issue number1
DOIs
StatePublished - Jan 2005

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Primary Hyperparathyroidism
Bone
Placebos
Calcium
Serum
Bone Density
Minerals
Plasmas
Calcium-Sensing Receptors
Biochemistry
Aptitude
Cinacalcet Hydrochloride
Bone Remodeling
Bone Resorption
Titration
Osteogenesis
Fasting
Maintenance
Urine
Safety

ASJC Scopus subject areas

  • Biochemistry
  • Endocrinology, Diabetes and Metabolism

Cite this

Cinacalcet hydrochloride maintains long-term normocalcemia in patients with primary hyperparathyroidism. / Peacock, Munro; Bilezikian, John P.; Klassen, Preston S.; Guo, Matthew D.; Turner, Stewart A.; Shoback, Dolores.

In: Journal of Clinical Endocrinology and Metabolism, Vol. 90, No. 1, 01.2005, p. 135-141.

Research output: Contribution to journalArticle

Peacock, Munro ; Bilezikian, John P. ; Klassen, Preston S. ; Guo, Matthew D. ; Turner, Stewart A. ; Shoback, Dolores. / Cinacalcet hydrochloride maintains long-term normocalcemia in patients with primary hyperparathyroidism. In: Journal of Clinical Endocrinology and Metabolism. 2005 ; Vol. 90, No. 1. pp. 135-141.
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